Endometrial Fluid Study in Natural Cycles: a Prospective Observational Study

NCT ID: NCT03909230

Last Updated: 2021-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-02

Study Completion Date

2019-05-27

Brief Summary

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This study is designed to collect information about the characteristics of endometrial fluid at day 2 and day 4 post-ovulation in normal fertile women.

Detailed Description

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Implantation rates have stabilised around 35% in IVF and a current key rate limiting step is achieving successful implantation of the embryo. 1/3 of implantation failures are estimated to be caused by a problem with the receptivity of the endometrium. In recent years, several measurable parameters have been reported to assess endometrial receptivity. However, one parameter remains undescribed, the endometrial fluid viscosity.

It is generally believed that the viscosity change post ovulation is influenced by the luteal phase endocrine milieu, and it is possible that the viscosity of the endometrial fluid has an impact on implantation.

Conditions

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Endometrial Fluid

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Day 2 post ovulation

Ultrasound of the endometrium, Endometrial fluid sample, Blood sample

No interventions assigned to this group

Day 4 post ovulation

Ultrasound of the endometrium, Endometrial fluid sample, Blood sample

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age: ≤ 35 years
* Women eligible and qualified for egg donation at IVIRMA Bilbao
* Proven fertile (having given birth to at least one spontaneously conceived normal child)
* Signed written consent including sharing of anonymized data

Exclusion Criteria

* Contraindications for egg donation according to IVIRMA Bilbao guidelines
Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Anecova SA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IVIRMA Bilbao

Leioa, Vizcaya, Spain

Site Status

Countries

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Spain

Other Identifiers

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NCV-VIS-001

Identifier Type: -

Identifier Source: org_study_id

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